Batch Release Pharmacist
2 weeks ago
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Job Purpose
- To provide cross-functional support, ensuring stock security (out of stock, stock to norm, new launches)
- To liaise with commercial and supply chain teams
- To request and review batch documentation and samples for product release to market.
- To approve batch reviews and release stock to market.
- To conduct self-inspections and provide support during Internal audits and CAPA closure
- To provide support to QMS in deviations and CR in supporting data
- To maintain the Batch release training module and to utilize this module to train colleagues identified to perform batch review.
- To generate Risk release reports, daily Lot release status reports, and monthly Q+R reports
- To review release reports for continued relevance and either update or close off the reports upon receipt of SAHPRA post registration amendment approvals.
- To compile the data required for the submission of PIT exemption applications.
- To provide support for the downloading of data loggers, training and datalogger manual compilation
- To provide support to the Batch release manager with respect to the compilation and maintenance of applicable departmental SOP's.
- To provide support to the Batch release manager with respect to the monthly Q and R report.
Accountabilities
- Perform Batch Reviews
- Perform Batch Release/Approvals
- Lot release of Vaccines
- Lot release of other Biologicals
- Maintenance and utilization of the Batch release training module for new reviewers
- Generation, review and update of release reports
- Type 1A variations
- Collation of data required for the application of exemption of PIT
- Provides Batch Release support with downloading of data loggers.
- Develops and maintains SOP's.
- Provides support to the Batch Release Manager
- Training
- Managing direct report/s
- Pharmacovigilance
- Any other reasonable duties
Education Qualification
- B.Pharm
Relevant Work Experience
- Pharmaceutical industry experience would be essential
- Quality assurance knowledge would be essential
- Experience in Lot Release would be beneficial
- Experience in Regulatory would be beneficial
- Experience in Supply chain would be beneficial
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